Experience Areas

Our experience areas include but not limited to -

• Creation and maintenance of Standard Operating Procedures
• Protocol review and providing inputs to the DM section of the protocol
• Creation and maintenance of DM documents (Data management plan, Edit check specifications, Data entry guidelines, Self evident corrections etc)
• CRF designing
• Database design and Edit check programming
• Data entry and validation, discrepancy management (Paper/EDC)
• Medical Coding - Medical term coding MedDRA,WHODD
• Serious Adverse event reconciliation
• Quality control audits